Pioglitazone Teva

pioglitazone

About

This is a summary of the European public assessment report (EPAR) for Pioglitazone Teva. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Pioglitazone Teva.

Pioglitazone Teva is used to treat type 2 diabetes in adults (aged 18 years or over), particularly those who are overweight. It is used in addition to diet and exercise.

Pioglitazone Teva is used on its own in patients for whom metformin (another antidiabetes medicine) is not suitable.

Pioglitazone Teva can also be used in combination with metformin in patients who are not satisfactorily controlled on metformin alone, or with a sulphonylurea (another type of antidiabetes medicine) when metformin is not suitable (‘dual therapy’).

Pioglitazone Teva can also be used together with both metformin and a sulphonylurea in patients who are not satisfactorily controlled despite dual therapy by mouth (‘triple therapy’).

Pioglitazone Teva can also be used together with insulin in patients who are not satisfactorily controlled with insulin alone and cannot take metformin.

The recommended starting dose of Pioglitazone Teva is 15 or 30 mg once a day. This dose may need to be increased after one or two weeks to up to 45 mg once a day if better blood glucose (sugar) control is needed. Pioglitazone Teva should not be used in patients on dialysis (a blood clearance technique used in people with kidney disease). The tablets should be swallowed with water.

Treatment with Pioglitazone Teva should be reviewed after three to six months, and discontinued in patients who are not deriving sufficient benefit. At subsequent reviews prescribers should confirm that benefits to patients are maintained.

Type 2 diabetes is a disease in which the pancreas does not make enough insulin to control the level of glucose in the blood or when the body is unable to use insulin effectively. The active substance in Pioglitazone Teva, pioglitazone, makes cells (fat, muscle and liver) more sensitive to insulin, which means that the body makes better use of the insulin it produces. As a consequence, the blood glucose levels are reduced and this helps to control type 2 diabetes.

Because Pioglitazone Teva is a generic medicine, studies in patients have been limited to tests to determine that it is bioequivalent to the reference medicine, Actos. Two medicines are bioequivalent when they produce the same levels of the active substance in the body.

The CHMP concluded that, in accordance with EU requirements, Pioglitazone Teva has been shown to have comparable quality and to be bioequivalent to Actos. Therefore, the CHMP’s view was that, as for Actos, the benefit outweighs the identified risk. The Committee recommended that Pioglitazone Teva be given marketing authorisation.

A generic medicine is a medicine which is similar to a medicine that has already been authorised (the 'reference medicine'). A generic medicine contains the same quantity of active substance(s) as the reference medicine. Generic and reference medicines are used at the same dose to treat the same disease, and they are equally safe and effective.

Publication details

Publication details for Pioglitazone Teva

Marketing-authorisation holder

Teva B.V.

Revision

6

Date of issue of marketing authorisation valid throughout the European Union

Pharmacotherapeutic group

Therapeutic indication

Pioglitazone is indicated in the treatment of type 2 diabetes mellitus:

as monotherapy- in adult patients (particularly overweight patients) inadequately controlled by diet and exercise for whom metformin is inappropriate because of contraindications or intolerance

as dual oral therapy in combination with- metformin, in adult patients (particularly overweight patients) with insufficient glycaemic control despite maximal tolerated dose of monotherapy with metformin- a sulphonylurea, only in adult patients who show intolerance to metformin or for whom metformin is contraindicated, with insufficient glycaemic control despite maximal tolerated dose of monotherapy with a sulphonylurea

Pioglitazone is also indicated for combination with insulin in type 2 diabetes mellitus adult patients with insufficient glycaemic control on insulin for whom metformin is inappropriate because of contraindications or intolerance.

After initiation of therapy with pioglitazone, patients should be reviewed after 3 to 6 months to assess adequacy of response to treatment (e.g. reduction in HbA1c). In patients who fail to show an adequate response, pioglitazone should be discontinued. In light of potential risks with prolonged therapy, prescribers should confirm at subsequent routine reviews that the benefit of pioglitazone is maintained.